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1.1 This test method covers poly(L-lactic acid) resin intended for use in surgical implants.
1.2 The requirements of this test method apply to poly(Llactic acid) in various forms:
1.2.1 Virgin polymer, or
1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO 10993–9 Biological Evaluation of Medical DevicesPart 9 Framework for Identification and Quantification of Potential Degradation Products ISO 13781 Poly(L-lactide) resins and fabricated forms for surgical implants In vitro degradation testing ISO 31–8 Physical Chemistry and Molecular Physics - Part 8: Quantities and Units
D638 Test Method for Tensile Properties of Plastics
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D695 Test Method for Compressive Properties of Rigid Plastics
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
D1708 Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
D1822 Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
D2857 Practice for Dilute Solution Viscosity of Polymers
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
NIST StandardNIST Special Publication SP811
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products); 13111000(Resins)
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ASTM F1635-95, Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants, ASTM International, West Conshohocken, PA, 2000, www.astm.orgBack to Top